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Intraoperative use of tranexamic acid to reduce blood loss during cytoreductive surgery for advanced ovarian cancer: A randomized controlled clinical trial
Yang X, Chai M, Xia L, He Z, Wu X, Zhang J
Acta obstetricia et gynecologica Scandinavica. 2023
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Abstract
INTRODUCTION Tranexamic acid reduces blood loss and allogeneic transfusion requirements in various surgical procedures. The role of tranexamic acid during cytoreductive procedures in advanced ovarian cancer is not clear. MATERIAL AND METHODS This was a single center randomized, controlled, three-armed clinical trial. A total of 150 ovarian cancer patients undergoing cytoreductive surgery were recruited and assigned to three groups (n = 50/group): the control group (normal saline), low-dose group (10 mg/kg bolus + 1 mg/kg continuous infusion of tranexamic acid), and high-dose group (20 mg/kg bolus + 5 mg/kg continuous infusion of tranexamic acid). The primary endpoint was intraoperative blood loss volume and total blood loss volume, and secondary endpoints included intraoperative blood transfusion volumes, vasoactive agent consumption, admission into the intensive care unit, and incidence of postoperative complications within postoperative 30 days. The study was registered at ClinicalTrials.gov ID: NCT04360629. RESULTS The patients in the high-dose group had less intraoperative (median [IQR]: 625.3 mL [343.5-1210.5]) and total blood loss volume (748.9 mL [292.2-1650.2]) than those in the control group (1015.5 mL [679.4-1015.5], p = 0.012; and 1700.7 mL [458.7-2419.8], p = 0.004, respectively). In contrast, the intraoperative (992.5 mL [539.0-1404.0], p = 0.874) and total blood loss volume (1025.0 mL [381.8-1819.9], p = 0.113) was not significantly reduced in the low-dose group when compared with the control group. Correspondingly, the relative risk of blood transfusion (RR [95% CI], 0.405 [0.180-0.909], p = 0.028) was reduced in the high-dose group and required less intraoperative noradrenaline (881.0 ± 438.3 mg) to maintain stable hemodynamics than the control group (1548.0 ± 349.8 mg, p = 0.001). Furthermore, compared with the control group, the two tranexamic acid groups had decreased intensive care unit admission rates (p = 0.016) without increasing the incidence of postoperative seizure, acute kidney injury, and thromboembolism. CONCLUSIONS High-dose tranexamic acid is more effective in reducing blood loss and blood transfusion without increasing the risk of postoperative complications. The high-dose regime tended to have a better risk-benefit profile.
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The efficacy of tranexamic acid treatment with different time and doses for traumatic brain injury: a systematic review and meta-analysis
Huang H, Xin M, Wu X, Liu J, Zhang W, Yang K, Zhang J
Thrombosis journal. 2022;20(1):79
Abstract
OBJECTIVE Tranexamic acid (TXA) plays a significant role in the treatment of traumatic diseases. However, its effectiveness in patients with traumatic brain injury (TBI) seems to be contradictory, according to the recent publication of several meta-analyses. We aimed to determine the efficacy of TXA treatment at different times and doses for TBI treatment. METHODS PubMed, MEDLINE, EMBASE, Cochrane Library, and Google Scholar were searched for randomized controlled trials that compared TXA and a placebo in adults and adolescents (≥ 15 years of age) with TBI up to January 31, 2022. Two authors independently abstracted the data and assessed the quality of evidence. RESULTS Of the identified 673 studies, 13 involving 18,675 patients met our inclusion criteria. TXA had no effect on mortality (risk ratio (RR) 0.99; 95% confidence interval (CI) 0.92-1.06), adverse events (RR 0.93, 95% Cl 0.76-1.14), severe TBI (Glasgow Coma Scale score from 3 to 8) (RR 0.99, 95% Cl 0.94-1.05), unfavorable Glasgow Outcome Scale (GOS < 4) (RR 0.96, 95% Cl 0.82-1.11), neurosurgical intervention (RR 1.11, 95% Cl 0.89-1.38), or rebleeding (RR 0.97, 95% Cl 0.82-1.16). TXA might reduce the mean hemorrhage volume on subsequent imaging (standardized mean difference, -0.35; 95% CI [-0.62, -0.08]). CONCLUSION TXA at different times and doses was associated with reduced mean bleeding but not with mortality, adverse events, neurosurgical intervention, and rebleeding. More research data is needed on different detection indexes and levels of TXA in patients with TBI, as compared to those not receiving TXA; although the prognostic outcome for all harm outcomes was not affected, the potential for harm was not ruled out. TRIAL REGISTRATION The review protocol was registered in the PROSPERO International Prospective Register of Systematic Reviews (CRD42022300484).
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[A multicenter, double-blind, randomized controlled clinical trial comparing ergometrine with oxytocin and oxytocin alone for prevention of postpartum hemorrhage at cesarean section]
He GL, Pan TY, Liu XX, He SY, Zhang L, Feng WS, Zhang J, He J, Xin W, Zhou YL, et al
Zhonghua fu chan ke za zhi. 2022;57(11):836-842
Abstract
Objective: To compare oxytocin combined with ergometrine with oxytocin alone in terms of primary prophylaxis for postpartum hemorrhage (PPH) at the time of cesarean section (CS). Methods: This was a multicenter double-blind randomized controlled interventional study comparing ergometrine combined with oxytocin and oxytocin alone administered at CS. From December 2018 to November 2019, a total of 298 parturients were enrolled in 16 hospitals nationwide. They were randomly divided into experimental group (ergometrine intra-myometrial injection following oxytocin intravenously; 148 cases) and control group (oxytocin intra-myometrial injection following oxytocin intravenously; 150 cases) according to 1∶1 random allocation. The following indexes were compared between the two groups: (1) main index: blood loss 2 hours (h) after delivery; (2) secondary indicators: postpartum blood loss at 6 h and 24 h, placental retention time, incidence of PPH, the proportion of additional use of uterine contraction drugs, hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery, the proportion requiring blood transfusion, and the proportion of prolonged hospital stay due to poor uterine involution; (3) safety indicators: nausea, vomiting, dizziness and other adverse reactions, and blood pressure at each time point of administration. Results: (1) The blood loss at 2 h after delivery in the experimental group [(402±18) ml] was less than that in the control group [(505±18) ml], and the difference was statistically significant (P<0.05). (2) The blood loss at 6 h and 24 h after delivery in the experimental group were less than those in the control group, and the differences were statistically significant (all P<0.05). There were no significant differences between the two groups in the incidence of PPH, the proportion of additional use of uterine contraction drugs, hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery, the proportion requiring blood transfusion, and the proportion of prolonged hospital stay due to poor uterine involution (all P>0.05). (3) Adverse reactions occurred in 2 cases (1.4%, 2/148) in the experimental group and 1 case (0.7%, 1/150) in the control group. There was no significant difference between the two groups (P>0.05). The systolic blood pressure within 2.0 h and diastolic blood pressure within 1.5 h of drug administration in the experimental group were higher than those in the control group, and the differences were statistically significant (P<0.05), but the blood pressure of the two groups were in the normal range. Conclusion: The use of ergometrine injection in CS could reduce the amount of PPH, which is safe and feasible.
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Effectiveness of shengxuexiaoban capsules combined with glucocorticoid therapy for immune thrombocytopenia: A meta-analysis
Ding MY, Li B, Yang M, Zhai WS, Song CD, Zhang J, Zhang QY, Li PF, Liu LY
PloS one. 2022;17(9):e0275122
Abstract
OBJECTIVE To evaluate the effectiveness of the Shengxuexiaoban Capsules combined with glucocorticoid therapy for immune thrombocytopenia (ITP). METHODS We collected randomized controlled trials (RCTs) using shengxuexiaoban capsules in combination with glucocorticoid to treat ITP by searching major Chinese and English electronic databases. The outcome indicators were the effective rate, recurrence rate, the number of platelets in the blood, recovery time of platelets, and adverse reactions. We used STATA 16.0 and RevMan 5.3 for meta-analysis and GRADE pro. for evidence quality evaluation. RESULTS A total of 27 RCTs were included in the meta-analysis, and the results showed a significant difference (all p<0.05) in the effective rate, recurrence rate, the number of platelets, and the recovery time of platelets (≥ 100×109) between ITP patients in the control group (who received glucocorticoid therapy alone) and test group (who received glucocorticoid therapy combined with the Shengxuexiaoban Capsules). And that Shengxuexiaoban capsules combined with glucocorticoid therapy were safe. The funnel plot and Egger's test results indicated no obvious publication bias. The GRADE evidence rating showed an intermediate quality of evidence rating for recurrence rate and overall effectiveness. CONCLUSION Glucocorticoid therapy combined with the Shengxuexiaoban Capsules showed more effectiveness in the treatment of ITP. It can improve the effective rate, reduce the recurrence rate, increase the number of platelets and shorten the recovery time of platelets, and has a good safety profile.
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A randomized controlled trial to compare the efficacy of regenerated and non-regenerated oxidized cellulose gauze for the secondary treatment of local bleeding in patients undergoing hepatic resection
Zhang C, Fu D, Wang F, Zhong X, Yang L, Wu G, Li B, Zhang J
Annals of surgical treatment and research. 2021;100(4):193-199
Abstract
PURPOSE Oxidized cellulose is available in many forms, but manufactured using either a regenerated or non-regenerated process. In this study, we evaluated the effects of 2 different hemostatic agents for the treatment of local bleeding in patients undergoing hepatic resection. METHODS This was a monocentric, parallel-group, randomized, and controlled clinical trial to compare oxidized regenerated cellulose gauze (ORCG) with oxidized non-regenerated cellulose gauze (ONRCG) in patients undergoing hepatectomy. The primary endpoint was the time to hemostasis at the target bleeding site. The secondary endpoints were the postoperative drainage volume on the first 2 days after surgery and the hospital stay. RESULTS There was no significant difference between the ORCG and ONRCG groups in time to hemostasis from column analysis (238.8 ± 121.6 seconds vs. 193.7 ± 85.3 seconds, P = 0.068), and there were no differences in the rates of hemostatic success between the 2 groups at 120 seconds (18.4% vs. 24.3%; odds ratio [OR], 0.703; 95% confidence interval [CI], 0.231-2.136) and 300 seconds (71.1% vs. 89.2%; OR, 0.298; 95% CI, 0.085-1.041). However, the ONRCG group was superior to the ORCG group in hemostasis according to the survival analysis (log-rank test, P = 0.044). Moreover, there were also no significant differences between the 2 groups in postoperative drainage volume on the first 2 days (P = 0.436, P = 0.381) and hospital stay (P = 0.537, P = 0.200). CONCLUSION ONRCG was not inferior to ORCG as a hemostatic agent in patients undergoing liver resection.
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EXPRESS: Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage: A Proof-of-Concept Randomized Controlled Trial
Zhao W, Jiang F, Li S, Liu G, Wu C, Wang Y, Ren C, Zhang J, Gu F, Zhang Q, et al
International journal of stroke : official journal of the International Stroke Society. 2021;:17474930211006580
Abstract
Background Remote ischemic conditioning (RIC) can promote hematoma resolution, attenuate brain edema, and improve neurological recovery in animal models of intracerebral hemorrhage (ICH). Aims This study aimed to evaluate the safety and preliminary efficacy of RIC in patients with ICH.Methods In this multicenter, randomized, controlled trial, 40 subjects with supratentorial ICH presenting within 24-48 hours of onset were randomly assigned to receive medical therapy plus RIC for consecutive 7 days or medical therapy alone. The primary safety outcome was neurological deterioration within 7 days of enrollment, and the primary efficacy outcome was the changes of hematoma volume on CT images. Other outcomes included hematoma resolution rate at 7 d ([hematoma volume at 7 d â hematoma volume at baseline]/hematoma volume at baseline), perihematomal edema (PHE), and functional outcome at 90 days. Results The mean age was 59.3±11.7 years and hematoma volume was 13.9±4.5 mL. No subjects experienced neurological deterioration within 7 days of enrollment, and no subject died or experienced RIC-associated adverse events during the study period. At baseline, the hematoma volumes were 14.19±5.07 mL in the control group and 13.55±3.99 mL in the RIC group, and they were 8.54±3.99 mL and 6.95±2.71 mL at 7 days after enrollment, respectively, not a significant difference (p>0.05 each). The hematoma resolution rate in the RIC group (49.25±9.17%) was significantly higher than in the control group (41.92±9.14%; MD, 7.3%; 95% CI, 1.51% to 13.16%; p=0.015). The absolute PHE volume was 17.27±8.34 mL in the control group and 12.92±7.30 mL in the RIC group at 7 days after enrollment, not a significant between-group difference (p=0.087), but the relative PHE in the RIC group (1.77±0.39) was significantly lower than in the control group (2.02±0.27; MD, 0.25; 95% CI, 0.39-0.47; p=0.023). At 90-day follow-up, 13 subjects (65%) in the RIC group and 12 subjects (60%) in the control group achieved favorable functional outcomes (mRS scoreâ¤3), not a significant between-group difference (p=0.744).Conclusions Repeated daily RIC for consecutive 7 days was safe and well-tolerated in patients with ICH, and it may be able to improve hematoma resolution rate and reduce relative PHE. However, effects RIC on the absolute hematoma and PHE volume and functional outcomes in this patient population need further investigations.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03930940.
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A Systematic Review of Minimally Invasive Treatments for Uterine Fibroid-Related Bleeding
Zhang J, Go VA, Blanck JF, Singh B
Reproductive sciences (Thousand Oaks, Calif.). 2021
Abstract
Newer minimally invasive techniques provide treatment options for symptomatic uterine fibroids while allowing uterus preservation. The objective of this review was to analyze the efficacy of uterine-preserving, minimally invasive treatment modalities in reducing fibroid-related bleeding. A comprehensive search was conducted of PubMed, Embase, PsycINFO, ClinicalTrials.gov, Scopus, and Cochrane Library databases from inception to July 2020. English-language publications that evaluated premenopausal women with fibroid-related bleeding symptoms before and after treatment were considered. Randomized controlled trials were assessed for bias with the established Cochrane Risk of Bias Tool 2.0 and observational studies were assessed for quality under the New Castle-Ottawa Scale guidelines. Eighty-four studies were included in the review, including 10 randomized controlled trials and 74 observational studies. Six studies on myomectomy demonstrated overall bleeding symptom improvement in up to 95.9% of patients, though there was no significant difference between mode of myomectomy. Forty-one studies on uterine artery embolization reported significant reduction of fibroid-related bleeding, with symptomatic improvement in 79 to 98.5% of patients. Three studies suggested that embolization may be superior to myomectomy in reducing fibroid-related bleeding. Six studies reported that laparoscopic uterine artery occlusion combined with myomectomy led to greater reduction of bleeding than myomectomy alone. Fifteen studies demonstrated significantly reduced bleeding severity after radiofrequency ablation (RFA). Additional research is needed to establish the superiority of these modalities over one another. Long-term evidence is limited in current literature for magnetic resonance-guided focused ultrasound surgery, cryomyolysis, microwave ablation, and laser ablation.
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Tranexamic acid given into wound reduces postoperative drainage, blood loss, and hospital stay in spinal surgeries: a meta-analysis
Hui S, Peng Y, Tao L, Wang S, Yang Y, Du Y, Zhang J, Zhuang Q
Journal of orthopaedic surgery and research. 2021;16(1):401
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Editor's Choice
Abstract
BACKGROUND Although intravenous tranexamic acid administration (ivTXA) has prevailed in clinical antifibrinolytic treatment, whether it increases thromboembolic risks has remained controversial. As a potent alternative to ivTXA, topical use of TXA (tTXA) has been successfully applied to attenuate blood loss in various surgical fields while minimizing systemic exposure to TXA. This meta-analysis was conducted to gather scientific evidence for tTXA efficacy on reducing postoperative drainage, blood loss, and the length of hospital stay in spine surgeries. OBJECTIVES To examine whether topical use of TXA (tTXA) reduces postoperative drainage output and duration, hidden blood loss, hemoglobin level drop, hospital stay, and adverse event rate, we reviewed both randomized and non-randomized controlled trials that assessed the aforementioned efficacies of tTXA compared with placebo in patients undergoing cervical, thoracic, or lumbar spinal surgeries. METHODS An exhaustive literature search was conducted in MEDLINE and EMBASE databases from January 2000 through March 2020. Measurable outcomes were pooled using Review Manager (RevMan) version 5.0 in a meta-analysis. RESULTS Significantly reduced postoperative drainage output (weighted mean difference [WMD]= - 160.62 ml, 95% confidence interval (95% CI) [- 203.41, - 117.83]; p < .00001) and duration (WMD= - 0.75 days, 95% CI [- 1.09, - 0.40]; p < .0001), perioperative hidden blood loss (WMD= - 91.18ml, 95% CI [- 121.42, - 60.94]; p < .00001), and length of hospital stay (WMD= - 1.32 days, 95% CI [- 1.90, - 0.74]; p < .00001) were observed in tTXA group. Pooled effect for Hb level drop with tTXA vs placebo crossed the equivalent line by a mere 0.05 g/dL, with the predominant distribution of 95% confidence interval (CI) favoring tTXA use. CONCLUSIONS With the most comprehensive literature inclusion up to the present, this meta-analysis suggests that tTXA use in spinal surgeries significantly reduces postoperative drainage, hidden blood loss, and hospital stay duration. The pooled effect also suggests that tTXA appears more effective than placebo in preserving postoperative Hb level, which needs further validation by future studies.
PICO Summary
Population
Patients undergoing spinal surgery (13 studies).
Intervention
Topical use of tranexamic acid (tTXA).
Comparison
Placebo.
Outcome
Those in the tTXA group showed significantly reduced postoperative drainage output (weighted mean difference (WMD) = - 160.62 ml) and duration (WMD = - 0.75 days), perioperative hidden blood loss (WMD = - 91.18ml), and length of hospital stay (WMD = - 1.32 days).
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Effect of Multiple Doses of Intravenous Tranexamic Acid on Perioperative Blood Loss in Total Knee Arthroplasty: A Randomized Controlled Study
Kang BX, Li YL, Xu H, Gao CX, Zhong S, Zhang J, Xie J, Sun ST, Xu XR, Zhao C, et al
Orthopaedic surgery. 2021;13(1):126-133
Abstract
OBJECTIVE To identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) following primary total knee arthroplasty (TKA) with a tourniquet. METHODS This is a single-blind randomized controlled study that recruited osteoarthritis patients who had undergone primary unilateral TKA from May 2019 to May 2020 at our medical center. A total of 300 patients were randomly divided into three groups to receive: one dose (1 g) of IV-TXA before skin incision combined with one dose (1.5 g) of intra-articular tranexamic acid(IA-TXA) followed by a single dose of IV-TXA (1 g) for 3 h (group A); two doses of IV-TXA (1 g) for 3 and 6 h (group B); or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group C) postoperatively. TKA with a tourniquet was performed by the same surgical team. The primary outcomes were total blood cell loss (TBL), hidden blood loss (HBL), maximum hemoglobin (Hb) drop, and transfusion rate. Secondary outcomes were levels of C-reactive protein (CRP) and D-dimer, and the incidence of postoperative complications. One-way analysis of variance, subgroup analysis, and multivariate correlation analysis were used to calculate the differences among the three groups. RESULTS The study included 56 male and 244 female patients aged 60-80 years. The mean TBL, the mean HBL, and the maximum Hb drop in group C (471.2 ± 190.6 mL, 428.4 ± 190.3 mL, and 21.2 ± 3.8 g/L, respectively) were significantly lower than those in groups B (563.4 ± 224.6 mL, P = 0.030; 519.9 ± 226.4 mL, P = 0.033; and 23.2 ± 4.1 g/L, P = 0.001, respectively), and A (651.6 ± 254.1 mL, P < 0.001; 607.1 ± 254.3 mL, P < 0.001; and 25.1 ± 4.3 g/L, P < 0.001, respectively). No transfusions were required. The postoperative acute inflammatory reaction was less problematic for patients in Group C, and the incidence of thromboembolic events was similar among the groups (P > 0.05). In addition, there were positive correlations between the HBL and the tourniquet inflation time (r = 0.844, P < 0.001). Similarly, the level of CRP on POD1 (r = 0.393, P < 0.001) and POD3 (r = 0.149, P = 0.010), and the level of D-dimer on POD1 (r = 0.382, P < 0.001) were positively correlated with the HBL. CONCLUSION Three doses of postoperative IV-TXA decreased blood loss and diminished the postoperative inflammatory and fibrinolytic response more than a single dose or two doses in elderly patients following TKA without increasing the incidence of adverse events.
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Multiple intravenous tranexamic acid doses in total knee arthroplasty in patients with rheumatoid arthritis: a randomized controlled study
Kang BX, Xu H, Gao CX, Zhong S, Zhang J, Xie J, Sun ST, Ma YH, Xu XR, Zhao C, et al
BMC musculoskeletal disorders. 2021;22(1):425
Abstract
BACKGROUND We aimed to determine the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who had undergone primary unilateral total knee arthroplasty (TKA). METHODS For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants with RA, aged 50-75 years, who underwent unilateral primary TKA were recruited. The patients received one dose of 1 g IV-TXA 10 min before skin incision, followed by articular injection of 1.5 g tranexamic acid after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) level decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay. RESULTS The mean TBL, HBL, and maximum Hb level decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. The D-dimer level was lower in group B than in group A on postoperative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the groups (P > 0.05). CONCLUSION In patients with RA, three doses of postoperative IV-TXA further facilitated HBL and Hb level decrease without increasing the incidence of adverse events in a short period after TKA. TRIAL REGISTRATION The trial was registered in the Chinese Clinical Trial Registry ( ChiCTR1900025013 ).